Ureteric StonesPhase 4NCT02469766
Treatment of Upper Ureteric Stones
A Phase 4 study testing SWL, Semirigid URS and Flexible URS in people with Ureteric Stones, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Ureteric Stones
- What is being tested?
- SWL, Semirigid URS and Flexible URS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Radio-opaque stones
- less than or equal 1 cm
Who cannot join
- Active UTI
- Coagulopathy
- Pregnancy
- Ureteric stricture
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, Dakhlia, 35516
Muhammad M abdallateef, MD, 01009681644, seif_1901@yahoo.com
Ahmed R EL-Nahas, MD, +20502202222 ext. 1699, ar_el_nahas@yahoo.com
About this study
Official title: A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial
This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.
Read the detailed description
This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.
- Conditions
- Ureteric Stones
- Being tested
- SWL, Semirigid URS, Flexible URS
- Keywords
- ureteral stones, ureter, ureteroscopy, flexible, SWL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWLProcedure or surgery
Patients in this arm will undergo SWL
Semirigid URSProcedure or surgery
Patients in this arm will undergo semirigid URS
Flexible URSProcedure or surgery
Patients in this arm will undergo Flexible URS
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shockwaves | Active comparator | Patients in this arm will undergo SWL Receives: Procedure: SWL |
| Semirigid URS | Active comparator | Patients in this arm will undergo Semirigid Ureteroscopy Receives: Procedure: Semirigid URS |
| Flexible URS | Active comparator | Patients in this arm will undergo Flexible Ureteroscopy Receives: Procedure: Flexible URS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
The stone free rate will be evaluated with non-contrast CT
Measured: 3 months
Secondary outcomes (1)
Complication rate
Complications will be classified according to modified Clavien Dindo
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric StonesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhamad muhamad abdallateef, Mansoura University
- Investigators
- Ahmed M Shoma, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469766
- Sponsor's protocol ID
- upper ureteric stones
- Status last verified
- Aug 2016
- First submitted
- 9 Jun 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02469766
- Acronym / sponsor ID
- upper ureteric stones
- Conditions
- Ureteric Stones
- Keywords
- ureteral stones, ureter, ureteroscopy, flexible, SWL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.
Detailed description
This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shockwaves | Active comparator | Procedure: SWLPatients in this arm will undergo SWL |
| Semirigid URS | Active comparator | Procedure: Semirigid URSPatients in this arm will undergo Semirigid Ureteroscopy |
| Flexible URS | Active comparator | Procedure: Flexible URSPatients in this arm will undergo Flexible Ureteroscopy |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Radio-opaque stones
- less than or equal 1 cm
Key exclusion criteria (4 listed)
- Active UTI
- Coagulopathy
- Pregnancy
- Ureteric stricture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWLPatients in this arm will undergo SWL | Procedure or surgery | Extracorporeal Shockwaves |
| Semirigid URSPatients in this arm will undergo semirigid URS | Procedure or surgery | Semirigid URS |
| Flexible URSPatients in this arm will undergo Flexible URS | Procedure or surgery | Flexible URS |
Primary outcome
Stone free rate
Time frame: 3 months
The stone free rate will be evaluated with non-contrast CT
1 secondary outcome
Complication rate
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Shoma, MD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SWL, Semirigid URS and Flexible URS in people with Ureteric Stones, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhamad M abdallateef, MD (01009681644, seif_1901@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.